Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-29 @ 7:04 PM
Study NCT ID:
NCT01695850
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2012-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Double-blinded,Double-dummy Clinical Trial of Chinese Herbal Medicine (MaZiRenWan) for Functional Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000081226', 'term': 'Sennosides'}], 'ancestors': [{'id': 'D012676', 'term': 'Senna Extract'}, {'id': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010936', 'term': 'Plant Extracts'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 291}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-10', 'studyFirstSubmitDate': '2012-09-27', 'studyFirstSubmitQcDate': '2012-09-27', 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the responder rate for CSBM during the treatment period', 'timeFrame': '8 weeks', 'description': 'a clinically meaningful endpoint by combining an objective measure (number of bowel movement) with a subjective measure (feelings of patients as to completeness of defecation,Patients with a mean increase of ≧1 complete spontaneous bowel movement(CSBM)/wk compared with the baseline(wk1-2) will be defined as responders'}], 'secondaryOutcomes': [{'measure': 'the responder rate for CSBM during the follow-up period', 'timeFrame': '8 weeks', 'description': 'Participants with a mean increase of complete spontaneous bowel movement (CSBM)\\>=1 movement per week compared with the last 14 days of the run-in period were defined as responders'}, {'measure': 'Individual assessment of constipation and related symptoms', 'timeFrame': '18 weeks', 'description': 'severity of constipation, sensation of straining, incomplete evacuation, bloating, abdominal pain / cramping, nausea, and passing of gas) was recorded using a 7-point ordinal scale (0 = not at all and 6 = very severe'}, {'measure': 'the changes of colonic transit time', 'timeFrame': '18 weeks', 'description': 'It is estimated by using a commercially available radio-opaque Sitzmarks capsule (Konsyl Pharmaceuticals, US). Each gelatine capsule contained 24 barium sulphate embedded polyvinyl chloride markers measuring 1mmx4.5mm. Plain radiographs of the abdomen will be obtained after the swallow of capsule for five days (120 hours) before and after 8 weeks treatment period.'}, {'measure': 'Global symptom assessment', 'timeFrame': '18 weeks', 'description': 'Participants were asked to rate their impression of change in constipation by comparing with their baseline (Wk2) at the visits during the treatment (Wk6), end of treatment (Wk10) and end of follow-up (Wk18) with scores from 0 to 6 represented markedly worse or better respectively. The response categories were collapsed to simply "improved" for score 4 to 6, "same" for score 3 or "worse" for score 0 to 2.'}, {'measure': 'Success of blinding', 'timeFrame': '18 weeks', 'description': 'the success of blinding is evaluated for both investigator and patients as to whether CHM, WM or placebo had been taken'}, {'measure': 'safety profiles', 'timeFrame': '18 weeks', 'description': "Assessed by determining the important adverse events reported in the participants ' diaries, follow-up interviews,and clinical laboratory evaluationse.g., liver and renal function."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Randomized controlled trial', 'Drugs,Chinese Herbal', 'Constipation/drug therapy'], 'conditions': ['Functional Constipation', 'Gastrointestinal Disorders']}, 'referencesModule': {'references': [{'pmid': '29654915', 'type': 'DERIVED', 'citation': 'Zhong LLD, Cheng CW, Kun W, Dai L, Hu DD, Ning ZW, Xiao HT, Lin CY, Zhao L, Huang T, Tian K, Chan KH, Lam TW, Chen XR, Wong CT, Li M, Lu AP, Wu JCY, Bian ZX. Efficacy of MaZiRenWan, a Chinese Herbal Medicine, in Patients With Functional Constipation in a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2019 Jun;17(7):1303-1310.e18. doi: 10.1016/j.cgh.2018.04.005. Epub 2018 Apr 12.'}, {'pmid': '24180235', 'type': 'DERIVED', 'citation': 'Zhong LL, Cheng CW, Chan Y, Chan KH, Lam TW, Chen XR, Wong CT, Wu JC, Bian ZX. Chinese herbal medicine (Ma Zi Ren Wan) for functional constipation: study protocol for a prospective, double-blinded, double-dummy, randomized controlled trial. Trials. 2013 Nov 4;14:366. doi: 10.1186/1745-6215-14-366.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy and safety of a Chinese herbal proprietary medicine, MaZiRenWan (MZRW), by comparing with stimulant laxative western medicine (WM), senna, and placebo for patients with functional constipation (FC) in excessive TCM syndrome.', 'detailedDescription': 'Functional constipation (FC) is a common clinical complaint. Despite the effectiveness of MaZiRenWan (MZRW) for alleviating FC symptoms has been proofed in the previous study.Given the results of the dose determination study and placebo-controlled study of MZRW, we hypothesize that MZRW is more useful than senna (senokot), a commonly used WM drug for constipation, for FC patients in excessive TCM syndrome.This is a prospective, double-blind, double dummy, randomized, controlled trial. After a 2-week run-in, eligible FC patients (Rome III) in excessive TCM syndrome will randomly be assigned to CHM arm (MZRW and WM placebo), WM arm (senna and CHM placebo) or placebo arm (CHM placebo and WM placebo). Patients will undergo an 8-week treatment and an 8-week follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* either gender aged 18 to 65 years\n* have FC diagnosed as Rome III criterial\n* have diagnosis of Excessive Constipation according to the TCM theory\n* complete spontaneous bowel movement (CSBM) ≦2times/w\n* severity of constipation≧3pts (7 pts scale from 0 to 6pts) and the overall scoring of constipation-related symptoms≧6pts (6items in 7pts scale) for self symptom assessment in the run-in period\n* normal colonic evaluation (colonoscopy or barium enema) within 12 months\n* normal liver and renal function in blood test within 3 months\n\nExclusion Criteria:\n\n* drug-induced constipation\n* secondary causes of constipation (i.e. medical history of diabetes mellitus and thyroid disease)\n* abdominal surgery (i.e. Caesarean operation)\n* severe diseases (i.e. cancer and acute present asthma)\n* allergy to CHM (i.e. G6PD deficiency), senna and tartrazine\n* pregnancy or breast-feeding\n* psychiatric or addictive disorders'}, 'identificationModule': {'nctId': 'NCT01695850', 'briefTitle': 'A Double-blinded,Double-dummy Clinical Trial of Chinese Herbal Medicine (MaZiRenWan) for Functional Constipation', 'organization': {'class': 'OTHER', 'fullName': 'Hong Kong Baptist University'}, 'officialTitle': 'Chinese Herbal Medicine (MaZhiRenWan) for Functional Constipation: a Prospective, Double-blinded, Double-dummy, Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'HHSRF09101501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MZRW', 'description': 'MZRW is composed of Fructus Cannabis (HuoMaRen), Radix et Rhizoma Rhei (DaHuang), Radix Paeoniae Alba (BaiShao), Semen Armeniacae Amarum (KuXingRen), Fructus Aurantii Immaturus (ZhiShi) and Cortex Magnoliae Officinalis (HouPo).', 'interventionNames': ['Drug: MZRW', 'Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Senna', 'description': 'Senna is a stimulant laxative which facilitates the passage of stools by altering intestinal electrolyte transport and increasing intestinal motor activity.', 'interventionNames': ['Drug: Senna', 'Drug: placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo MZRW and Placebo Senna', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'MZRW', 'type': 'DRUG', 'otherNames': ['Hemp Seed Pill'], 'description': 'Patients are instructed to dissolve a sachet of granules (7.5g) in 150ml of hot water; they take this solution orally twice daily for 8 weeks.', 'armGroupLabels': ['MZRW']}, {'name': 'Senna', 'type': 'DRUG', 'otherNames': ['Senokot'], 'description': 'Patients are instructed to take 2 tablets at the bedtime for 8 weeks.', 'armGroupLabels': ['Senna']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'The placebo MZRW is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%) and caramel (0.34%) to achieve color, smell, taste and texture comparable to MZRW granules.The placebo Senna is made of starch and colour to achieve comparable appearance to Senokot.', 'armGroupLabels': ['MZRW', 'Placebo', 'Senna']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'state': 'Hong Kong', 'country': 'China', 'facility': 'School of Chinese Medicine, Hong Kong Baptist University', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Zhao Xiang Bian, MD, Ph. D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Chinese Medicine, Hong Kong Baptist University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hong Kong Baptist University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Queen Elizabeth Hospital, Hong Kong', 'class': 'OTHER'}, {'name': 'Prince of Wales Hospital, Shatin, Hong Kong', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'ZhaoXiang Bian', 'investigatorAffiliation': 'Hong Kong Baptist University'}}}}